FDA Enforcement
Class II
Terminated
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Recall: Z-1660-2015
·
Reported June 3, 2015
Enforcement
- Recall Number
- Z-1660-2015
- Event ID
- 71022
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Siemens Medical Solutions Diagnostics
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 3, 2015
- Initiation Date
- March 5, 2015
- Classification Date
- May 23, 2015
- Termination Date
- January 16, 2018
- Address
- 62 Flanders-Bartley Rd, Flanders, NJ, 07836-4715, United States
Description
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
Reason
The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.
Code Info
Accessory Kit - Product Code/Catalog #'s 10282965, 10373217 and 10286080
Distribution
Worldwide Distribution.
Quantity
962 bottles